Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female, age ≥ 18 yrs and ＜70 yrs with histologically or cytologically confirmed
Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1
Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
Predicted life expectancy of ≥ 3 months
Provision of written informed consent.
Inability to understand or cooperate with study procedures
Receipt of investigational drugs ≤ 30 days before study entry
Receipt of other investigational drugs during the course of this study
Seizure disorder or any condition requiring anticonvulsants, sedatives
CNS malignancy or metastasis
Ongoing emesis due to obstruction of digestive tract
Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
Moderate or severe nausea and vomiting after any previous chemotherapy
Scheduled receipt of any chemotherapeutic agent with an emetogenicity level ＞3 during study Days 2-5
Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5